TIADYLT ER

In shortageOrange BookUNIISPLATC C05AE03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7077110390
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1039-0)
ndc11
7077110391
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1039-1)
ndc11
7077110393
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1039-3)
ndc11
7077110395
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1039-5)
ndc11
7077110399
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1039-9)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

A206641

AB4AB4AB4AB4AB4AB4

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Diltiazem Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "OLH94387TE",
    "rxcui": "203211",
    "inchikey": "HDRXZJPWHTXQRI-BHDTVMLSSA-N",
    "display_name": "DILTIAZEM HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b4b4e53e-fc99-4f34-abc2-57e4f28aff84": {
      "match": "brand_token",
      "title": "TIADYLT ER (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2025-06-16"
    }
  },
  "productid": "70771-1039_302fc306-6fbe-4567-b5ce-dcc5a45ba894",
  "productndc": "70771-1039",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206641",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "360MG",
        "product_no": "005",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "420MG",
        "product_no": "006",
        "approval_date": "Aug 11, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DILTIAZEM HYDROCHLORIDE",
  "shortage_reason": "Diltiazem Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "TIADYLT ER",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206641",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diltiazem hydrochloride",
  "start_marketing_date": "20171108",
  "active_numerator_strength": "360"
}

Related drugs

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